MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number H802232390010

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual inspection was performed.The device has the guidewire broken by tension overload near to the distal section, 327 cm from the proximal section, also the body is kinked.The distal section was not returned.The overall length and outer diameter of distal tip couldn't be measured due to the device condition.The outer diameter of distal section end near the broken section is 0.0054 inch.The outer diameters of middle of the device and proximal section are within specifications.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2015.It was reported that a rotawire became kinked.The target lesion was located in the severely calcified left anterior descending artery to the first and second right posterolateral segment.During the procedure, when the rotablator was inserted, the rotawire got kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.However, device analysis revealed that the guidewire was broken.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5306995
• MDR Text Key: 33780438
• Report Number: 2134265-2015-08723
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802232390010
• Device Catalogue Number: 23239-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1